Merck’s Gardasil Is Required For US Immigrants
27 CommentsBy Ed Silverman // September 22nd, 2008 // 1:43 pm
The debate over mandatory vaccination for the controversial HPV vaccine has taken an interesting twist. As it turns out, the US Department of Homeland Security is requiring girls and young women who immigrate to the US to get the Gardasil jab, TheStreet.com reports.
And Homeland Security’s US Citizenship and Immigration Services is the first government agency to mandate that all females ages 11 to 26 years old be vaccinated against HPV, which can cause cervical cancer. Although only one dose is required, compared with three doses Merck says is needed for effectiveness. There is no requirement, by the way, for any other visa holders or US citizens.
Since the policy was begun, an estimated 233,000 females ages 11 to 26 entered the US as prospective citizens and paid a combined $52 million or so for one dose, based on the $223 cost for one treatment borne by the typical UK emigrant and average numbers taken from the Department of Homeland Security’s “Yearbook of Immigration Statistics” over a four-year period, The Street writes.
“I am stunned. It was not the intention of the policy to mandate vaccination of immigrants,” John Abramson, who was chairman of the CDC’s Advisory Committee for Immunization Practices when the requirement began in April 2007, and an opponent of mandatory vaccination, tells the Street. “This is not a disease that is communicable like SARS or pandemic flu or even measles.”
More than 20 states backed down from plans, supported by Merck, to make Gardasil mandatory. Parents and medical experts expressed concern about safety, perceived encouragement of sexual activity by youngsters, and effectiveness, TheStreet reminds us. Texas, for instance, rejected an executive order to mandate vaccination, and Virginia and Washington, DC, have opt-out clauses.
No opt-out provision exists for immigrants, TheStreet notes. The USCIS enforces CDC vaccination guidelines prepared by the Division of Global Migration and Quarantine, which refers to the Immigration and Nationality Act, or INA, as the legislation requiring the recommendations of the ACIP to be implemented. A Homeland Security spokesman declined to comment to TheStreet.
The State Department’s form DS-3025, or “vaccination documentation worksheet,” says vaccination against “Human Papillomavirus is required for US immigrant visa applicants.” Here is the form.
Charlotte Haug, editor in chief of the influential Journal of the Norwegian Medical Association, tells TheStreet “this is very surprising and makes no sense. Whether this vaccine works is still being discussed.” Ironically, Merck isn’t aware of the Homeland Security policy, according to a Merck spokeswoman.
Anne
They’re using immigrants as guinea pigs.
This is a big price to pay to come into the country. Not only has gardasil caused deaths and paralysis, spontaneous abortions, and more; but it’s also not a communicable disease. Check out Judicial Watch website or look for adverse reactions in VAERS - there are thousands.
Lizabeth
This is an outrageous abuse of power. Since HPV is a sexually transmitted disease, are they also requiring condom use? Just a give away to the company, and unethical.
Melody
Isn’t this an act of discrimination?
Justice in MI
“Ironically, Merck isn’t aware of the Homeland Security policy, according to a Merck spokeswoman.”
This would not seem possible, but I will accept it until proven otherwise. Is it a case of “It depends on what ‘is’ is?”
Also, wondering if there are any other vaccines required (without opt-out provisions) of immigrants that are not required of citizens.
Informed in NJ
Mr. Silverman,
I generally enjoy reading your blog, however, I continue to be dissapointed in the completeness (or lack thereof) of what you write.
In this current blog, why have you chosen to not infor your readers about all the ACIP recommended vaccines that are required by the Immigration and Nationality Act (INA)?
The anti vaccine rhetoric on this website is down-right scary…I hope Anne’s family members do not end up suffering from vaccine preventable disease - many of which are deadly. If we followed the advice of Judicail Watch, we would lose and estimated 1 million children a year to measles alone…
As for the risk/benefit ratio of Gardasil, I prefer to get my information from the CDC http://www.cdc.gov/vaccinesafety/vaers/FDA_and_CDC_Statement.htm
Chris
JiM -
This is most likely a case that the PR person (and perhaps her contact) were not aware of the Homeland Security policy. Somebody at Merck must have had some knowledge of this.
Justice in MI
Here ya, Chris. But the spokesperson ought to have said that if it’s true. Otherwise, it’s, well, lying.
Janet
I do think that Merck knows what is going on with the Homeland Security Act, as much as they would like to distance themselves from that fact/possibility. Aren’t they in a partnership of sorts?
Nathan
FYI, from Ed’s form above, here’s a list of the required vaccines:
Influenza
Hib
Varicella
DT DTP DTaP
Hepatitis B
Meningococcal
Td/ Tdap
Rotavirus
Hepatitis A
Human papillomavirus
Polio -OPV IPV
MMR (Measles-Mumps-Rubella)
Rubella
Pneumococcal
Measles
Measles - Rubella
Zoster
Informed in NJ
Thanks Nathan!
I’m so embarrased, I keep forgetting that I am reading work from Ed Silverman the blog writer rather than Ed Silverman to journalist. Ed Silveramn the journalist certainly would have been complete in his reporting and listed all the CDC (ACIP) recommended vaccinese required by the INA, therefore, this would have been a non story. However, Ed Silverman the blog write certainly has an agenda to put forth and prefers to tell partial truths that support his agenda…
Ed Silverman
Dear Informed,
To stay informed, please read the post closely. I linked to a story from TheStreet.com. If you click on the link, you can see the complete story, which I summarized in the post for the sake of brevity.
Moreover, as Nathan indicated in his comment above, the link to the State Department form includes the list of vaccines. You could have clicked on that link yourself. I provided the link so readers could see the list.
You accused me of having an agenda, but you make no specific claims. Are you referring to vaccines, in general, or Gardasil specifically? To keep it simple, vaccines are controversial, as news reports for many years have indicated. And Gardasil has been controversial for the reasons cited in TheStreet.com story, countless other news stories - including my own when I wrote for The Star-Ledger - and my own posts here on Pharmalot. Nothing new about that. As a journalist, I follow the controversy. And mandatory Gardasil vaccination is part of that story.
As for anti-vaccine rhetoric, please don’t confuse my posts with comments left by others. In fact, many people who visit this site are very much in favor of seeing the FDA approve the Provenge prostate cancer vaccine (do a search on Provenge, read the posts and then read the comments, and you’ll see what I mean).
There is no agenda here, and no bias for or against vaccines on my part. Those are personal decisions. My role here is to convey interesting info as I come across it. I hope this helps.
Regards
ed s
harpy
Considering how hard Merck was pushing to make it mandatory, I find it difficult to believe they don’t know about this. But then again, it is Homeland Security.
I wonder if Merck has any idea of the effects of partial immunity. Is there any danger of increasing resistance, much in the way of antibiotics, and breeding super-HPV?
And for the first poster, Anne, I agree that it’s a despicable use of immigrants as guinea pigs, but HPV is in fact communicable.
Nathan
By the way, from my reading, the requirement is for an “HPV vaccine” — NOT for Gardasil. Doesn’t GSK have an HPV vaccine on the market now? Probably others will follow too.
Ed Silverman
Hi Nathan,
Glaxo’s Cervarix is not yet available in the US. Here’s the back story…
http://www.pharmalot.com/2008/06/glaxo-hpv-vaccine-delayed-until-late-2009/
Regards,
ed
Justice in MI
What strikes me is that many in the U.S. who have been opposed to _mandatory_ HPV vaccination have been so on the basis of religious and family values convictions.
Have these voices even begun to be heard on this issue??
nipsey russell
Why would we care if bronze age superstitions were aired pro or con a public health measure??
nipsey russell
oh, nevermind, its the USA, silly me
Justice
Gardasil side effects prompt CDC study
August 13, 2008 — 6:06am ET | By Christe Bruderlin-Nelson
Tools
· Email
· Print
· Contact Author
Related Stories
· Will Gardasil special help Merck?
· Gardasil: Some good news for Merck
· Flat Gardasil sales trigger Merck sell-off
· Peto bristles at Vytorin-cancer questions
· FDA grants Gardasil two new indications
Merck is likely quite displeased with the barrage of negative press about its cervical cancer vaccine’s side effects, especially after a public interest group, Judicial Watch, released a report at the end of last month saying there were 9,749 adverse reactions and 21 reported deaths related to Gardasil in the last two years.
According to the report, there have been 78 severe outbreaks of genital warts, six cases of Guillain-Barré syndrome and at least 10 miscarriages reported to the Vaccine Adverse Event Reporting System (VAERS) since the approval of Gardasil. However, a study in the New England Journal of Medicine found that clinicians, patients and drug companies report only about 10 percent of side effects to VAERS, so the actual number of Gardasil side effects could be much higher.
Some experts say Merck has also overstated the vaccine’s effectiveness and that the evidence just isn’t there yet. In light of the potential side effects and the drugs’ young female target audience, many also are questioning Merck’s continual push to place the drug on state mandatory vaccine lists.
For its part, Merck says there is no evidence that the vaccine and the reported side effects and deaths are related, and the CDC plans to release a study in October that will help determine whether a true linkage between Gardasil and the reported adverse reactions exists.
- see more at News Inferno
- read the story at ABC
- get an alternative view at Natural News
Related Articles:
CDC details side effects reported on Gardasil
Gardasil: Some good news for Merck
Flat Gardasil sales trigger Merck sell-off
EMEA affirms Gardasil after two deaths
Lisa Van S
Informed in NJ,…
Are you really,.. its all in your name,. and lacks legitimacy! care to debate?
Lisa Van S
Justice,
This issue isnt about religion,..Its about safety. Folks need to get off their soap box!!
Christopher
Lisa,
There are plenty of people on soap boxes whose beliefs are very important to them and who take every opportunity to share their views with anyone in close range.
In this case, when HPV affects 20m in the USA alone, 5.5m new cases each year, and so many (up to 75%) of sexually active males and females likely to catch it at some time or other, this seems like an important cause. Especially when so many sexually active under 16s are affected.
But if somebody’s religious beliefs preclude such intervention - despite opposing wisdom from others not sharing those beliefs - it’s not enough to argue that it’s about safety and that is more important than other factors. Not from another soap box anyway.
Chris
Christopher -
Only a small fraction of those who have the HPV virus will get cancer, thus your numbers are somewhat deceptive. Plus other HPV strains can also cause cancer, Guardasil only addresses a couple of the major strains, and nobody knows how long the protection lasts.
As per Harpy’s comment - In modeling for ACIP, Merck assumed that there was no protection for those only getting one dose. Not sure how much that is based on scientific fact, but certainly interesting to note.
Christopher
Chris,
Thanks for the clarification. However, as far as I understand Gardasil protects against two of the highest risk strains which cause about 70% of cervical cancers. I know there are about a hunderd others and that most carriers of the virus will be fine, but my point with the statistics was to illustrate the size of the problem (as I see it) from which cervical cancers will result. If it can be prevented by vaccination it seems worthwhile, depending of course on one’s religious views.
Chris
If cervical cancer can be prevented by vaccination without risk, that is one thing. However, serious side effects including deaths have been reported, plus the length of effectiveness is unknown. To me, it is not clear that the best decision for a teenager is to get vaccinated. At best it is great that it is available for those who choose it.
Jack P
The US wants to make sure that all they young girls that aren’t killed by this poison can embrace the US slut-culture to the fullest.
harpy
The WSJ today says immigrant advocates and health policy experts are moving to have the recommendation withdrawn.
Donya
This is very concerning to those of us with children coming to the US. My natural born daughters are not required to have this vaccine and I feel my adopted daughter should have the same rights. I am worried about this vaccine and having been left without a choice on this. i am just praying she will be ok once it is administered. I feel terrible for the thousands of girls who have had terrible side effects from this vaccine. I hope the law changes.